Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects

Dorothy K. Hatsukami, Xianghua Luo, Alisa K. Heskin, Mei Kuen Tang, Steven G. Carmella, Joni Jensen, Jason D. Robinson, Ryan Vandrey, David J. Drobes, Andrew A. Strasser, Mustafa al'Absi, Scott Leischow, Paul M. Cinciripini, Joseph Koopmeiners, Joshua Ikuemonisan, Neal L. Benowitz, Eric C. Donny, Stephen S. Hecht

Research output: Contribution to journalArticle

Abstract

Aim: A previous study showed significantly greater reductions in number of cigarettes smoked and biomarkers of toxicant and carcinogen exposure in smokers assigned to immediate reduction of nicotine in cigarettes to very low levels versus gradually over time or continued smoking of normal nicotine content cigarettes. This study examines the effects of these approaches on selected biomarkers associated with harmful biological effects. Design: Three-arm, randomized controlled trial. Setting: Ten United States academic institutional sites. Participants: Daily smokers uninterested in quitting smoking with a mean age of 45.1 [standard deviation (SD) = 13.4)] years and smoking 17.1 (SD = 8.5) cigarettes/day; 43.9% (549 of 1250) female; 60.6% (758 of 1250) white ethnicity. Interventions: (1) Smoking cigarettes where nicotine content was immediately reduced to very low levels (n = 503); (2) smoking cigarettes where nicotine content was gradually reduced, with dose changes occurring monthly (n = 498); and (3) continued smoking with normal nicotine content cigarettes (n = 249). Measurements: Smokers were assessed at baseline while smoking their usual brand cigarettes, and again at 4, 8, 12, 16 and 20 weeks. Outcomes were areas under the concentration time curve (AUC) for the period of study of biomarkers of inflammation, oxidative stress and hematological parameters. Findings: No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference = −0.11; 95% confidence interval (CI) = –0.18, −0.04, P = 0.004] and normal nicotine control groups (mean difference = − 0.15, 95% CI = –0.23, −0.06, P = 0.001). Conclusion: It remains unclear whether switching to very low nicotine cigarettes leads to a short-term reduction in biomarkers of tobacco-related harm.

Original languageEnglish (US)
JournalAddiction
DOIs
StatePublished - Jan 1 2019
Externally publishedYes

Fingerprint

Nicotine
Tobacco Products
Biomarkers
Smoking
Confidence Intervals
Cell Size
Carcinogens
Area Under Curve
Tobacco
Oxidative Stress
Randomized Controlled Trials
Erythrocytes
Inflammation
Control Groups

Keywords

  • Biomarkers of biological effects
  • hematological parameters
  • immediate versus gradual nicotine reduction
  • inflammation
  • oxidative stress
  • reduced nicotine content cigarettes

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Psychiatry and Mental health

Cite this

Hatsukami, D. K., Luo, X., Heskin, A. K., Tang, M. K., Carmella, S. G., Jensen, J., ... Hecht, S. S. (2019). Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects. Addiction. https://doi.org/10.1111/add.14695

Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects. / Hatsukami, Dorothy K.; Luo, Xianghua; Heskin, Alisa K.; Tang, Mei Kuen; Carmella, Steven G.; Jensen, Joni; Robinson, Jason D.; Vandrey, Ryan; Drobes, David J.; Strasser, Andrew A.; al'Absi, Mustafa; Leischow, Scott; Cinciripini, Paul M.; Koopmeiners, Joseph; Ikuemonisan, Joshua; Benowitz, Neal L.; Donny, Eric C.; Hecht, Stephen S.

In: Addiction, 01.01.2019.

Research output: Contribution to journalArticle

Hatsukami, DK, Luo, X, Heskin, AK, Tang, MK, Carmella, SG, Jensen, J, Robinson, JD, Vandrey, R, Drobes, DJ, Strasser, AA, al'Absi, M, Leischow, S, Cinciripini, PM, Koopmeiners, J, Ikuemonisan, J, Benowitz, NL, Donny, EC & Hecht, SS 2019, 'Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects', Addiction. https://doi.org/10.1111/add.14695
Hatsukami, Dorothy K. ; Luo, Xianghua ; Heskin, Alisa K. ; Tang, Mei Kuen ; Carmella, Steven G. ; Jensen, Joni ; Robinson, Jason D. ; Vandrey, Ryan ; Drobes, David J. ; Strasser, Andrew A. ; al'Absi, Mustafa ; Leischow, Scott ; Cinciripini, Paul M. ; Koopmeiners, Joseph ; Ikuemonisan, Joshua ; Benowitz, Neal L. ; Donny, Eric C. ; Hecht, Stephen S. / Effects of immediate versus gradual nicotine reduction in cigarettes on biomarkers of biological effects. In: Addiction. 2019.
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AU - Hatsukami, Dorothy K.

AU - Luo, Xianghua

AU - Heskin, Alisa K.

AU - Tang, Mei Kuen

AU - Carmella, Steven G.

AU - Jensen, Joni

AU - Robinson, Jason D.

AU - Vandrey, Ryan

AU - Drobes, David J.

AU - Strasser, Andrew A.

AU - al'Absi, Mustafa

AU - Leischow, Scott

AU - Cinciripini, Paul M.

AU - Koopmeiners, Joseph

AU - Ikuemonisan, Joshua

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N2 - Aim: A previous study showed significantly greater reductions in number of cigarettes smoked and biomarkers of toxicant and carcinogen exposure in smokers assigned to immediate reduction of nicotine in cigarettes to very low levels versus gradually over time or continued smoking of normal nicotine content cigarettes. This study examines the effects of these approaches on selected biomarkers associated with harmful biological effects. Design: Three-arm, randomized controlled trial. Setting: Ten United States academic institutional sites. Participants: Daily smokers uninterested in quitting smoking with a mean age of 45.1 [standard deviation (SD) = 13.4)] years and smoking 17.1 (SD = 8.5) cigarettes/day; 43.9% (549 of 1250) female; 60.6% (758 of 1250) white ethnicity. Interventions: (1) Smoking cigarettes where nicotine content was immediately reduced to very low levels (n = 503); (2) smoking cigarettes where nicotine content was gradually reduced, with dose changes occurring monthly (n = 498); and (3) continued smoking with normal nicotine content cigarettes (n = 249). Measurements: Smokers were assessed at baseline while smoking their usual brand cigarettes, and again at 4, 8, 12, 16 and 20 weeks. Outcomes were areas under the concentration time curve (AUC) for the period of study of biomarkers of inflammation, oxidative stress and hematological parameters. Findings: No consistent significant differences were observed across groups (Bayes factors showing data to be insensitive), with the only exception being red blood cell size variability, which was observed to be lower in the immediate versus gradual nicotine reduction [mean difference = −0.11; 95% confidence interval (CI) = –0.18, −0.04, P = 0.004] and normal nicotine control groups (mean difference = − 0.15, 95% CI = –0.23, −0.06, P = 0.001). Conclusion: It remains unclear whether switching to very low nicotine cigarettes leads to a short-term reduction in biomarkers of tobacco-related harm.

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